Telehealth Program with Activity Monitor to Encourage Movement After Stroke
Tests a remote program, with or without a smartwatch, to help stroke survivors move more.
Plain-language title generated from the registry record
Registry title: Telehealth Intervention Involving HEARTS Technical Package and Activity Monitor to Promote Physical Activity Post-stroke
Key facts
- Where
- Belo Horizonte, BrazilSee the site
Where in Brazil
- Universidade Federal de Minas GeraisBelo Horizonte, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Federal University of Minas Gerais
- Trial code
- NCT06068036
- Record updated
- 27 February 2025
- Original description
Objectives: The aim of this feasibility randomized controlled trial (RCT) study is to investigate whether the theoretically informed telehealth intervention involving the HEARTS Technical Package and the use of an activity monitor to increase physical activity level post-stroke is feasible and to estimate the parameters for conducting a fully powered RCT.Read full original descriptionShow less
Telehealth Intervention Involving the HEARTS Technical Package and the Use of an Activity Monitor to Increase Physical Activity Level Post-stroke: a Feasibility Randomized Controlled Trial
Objectives: The aim of this feasibility randomized controlled trial (RCT) study is to investigate whether the theoretically informed telehealth intervention involving the HEARTS Technical Package and the use of an activity monitor to increase physical activity level post-stroke is feasible and to estimate the parameters for conducting a fully powered RCT.
Design: A Phase 1 feasibility RCT study with blinded assessment will assign eligible participants to experimental or control group. Participants in both groups will undergo a theoretically informed telehealth intervention based on the HEARTS technical package (a face-to-face session and telephone call follow-up). The experimental group will have additional use of the Mi Band 7® Smartwatch activity monitor. For both groups, the intervention will last for 12 weeks. The feasibility outcomes will be identified considering the different phases of conducting the study. A trained researcher, blinded to the group allocation, will collect the sociodemographic, anthropometric, and clinical outcomes, in a university laboratory setting.
Study Outcomes: Feasibility of recruitment, intervention, and measurement, and clinical outcomes.
Conclusions: Results from this feasibility RCT study will inform on the design and sample required for a fully powered RCT with a similar aim.
Inclusion: Diagnosis of stroke for more than six months; ≥18 years of age; Be rated as "Inactive" according to Human Activity Profile (HAP); Provide medical approval to practice physical activity.
Exclusion: Pain or other adverse health condition that compromises the performance of the proposed intervention program, such as vestibular disorders, severe arthritis or any other diagnosis of disease of the nervous system; Positive screening test for possible cognitive alterations.